Circulating Tumor DNA to Monitor Response to Neoadjuvant Chemotherapy in Breast Cancer

January 8, 2024 updated by: Liu Qiang, Sun Yat-Sen Memorial Hospital of Sun Yat-Sen University
Investigators aim to investigate whether circulating tumor DNA is a sensitive marker to evaluate patients' response to neoadjuvant chemotherapy

Study Overview

Status

Recruiting

Conditions

Detailed Description

Neoadjuvant chemotherapy(NAC) is traditionally for locally advanced disease, converting an inoperable to a resectable tumor.In recent years, it has become an option for patients of lower tumor stage to increase the possibility of breast conserving therapy. An effective method to monitor the response to NAC is important.

Study Type

Observational

Enrollment (Estimated)

150

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Locations

  • China
    • Guangdong
      • Guandong, Guangdong, China
        • Recruiting
        • Sunyat-sen Memorial Hospital
        • Contact:

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years to 70 years (Adult, Older Adult)

Accepts Healthy Volunteers

No

Sampling Method

Non-Probability Sample

Study Population

Breast cancer patient receiving NAC

Description

Inclusion Criteria:

  • Female patients undergoing NAC
  • Age: 18-70 yrs
  • Any menopausal status
  • Any hormal receptor status

Exclusion Criteria:

  • Metastasis discovered during NAC
  • Lost more than 2 blood samples during NAC and surgery

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
death of breast cancer
Time Frame: Follow-up time is estimated to be up to 5 years. The duration is from the date of diagnosis to date of death of breast cancer or date of death of any cause, whichever come first.
The event is defined as death of breast cancer, which is a separate measure
Follow-up time is estimated to be up to 5 years. The duration is from the date of diagnosis to date of death of breast cancer or date of death of any cause, whichever come first.

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
tumor recurrence or distant metastasis
Time Frame: Follow-up time is estimated to be up to 5 years.The duration is from diagnosis to local recurrence or distant metastasis of breast cancer. Patients were followed up every six months in first three years, then followed up once a year.
The event is defined as breast cancer local recurrence or distant metastasis
Follow-up time is estimated to be up to 5 years.The duration is from diagnosis to local recurrence or distant metastasis of breast cancer. Patients were followed up every six months in first three years, then followed up once a year.

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Sun Yat-Sen Memorial Hospital of Sun Yat-Sen University

Investigators

  • Principal Investigator: qiang Liu, Sun Yat-Sen Memorial Hospital of Sun Yat-Sen University

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

September 1, 2013

Primary Completion (Estimated)

December 1, 2025

Study Completion (Estimated)

December 1, 2025

Study Registration Dates

First Submitted

August 14, 2017

First Submitted That Met QC Criteria

August 21, 2017

First Posted (Actual)

August 24, 2017

Study Record Updates

Last Update Posted (Actual)

January 10, 2024

Last Update Submitted That Met QC Criteria

January 8, 2024

Last Verified

January 1, 2024

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • LQBC020

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

UNDECIDED

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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